MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ RESTOR SINGLEPIECE IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	SN6AD1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/07/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: the product was not returned for analysis; as it remains implanted.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There were no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported blurry vision at intermediate and distance and delay in focusing following cataract surgery with an intraocular lens (iol) implant.The consumer also reported that he had posterior capsule opacification in this eye and his doctor performed a yag laser.Six years later, the patient is reporting that his vision is worse and he cannot read.Additional information was provided by the consumer that he saw black articles floating around the iol in a video his surgeon provided.He also reported that he cannot drive at night.There are two medical device reports associated with this patient.This report is associated with the right eye.

• Brand Name: ACRYSOF IQ RESTOR SINGLEPIECE IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 12846852
• Report Number: 1119421-2021-02173
• Device Sequence Number: 17204869
• Product Code: MFK
• UDI-Device Identifier: 00380652241625
• UDI-Public: 00380652241625
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: SN6AD1
• Device Catalogue Number: SN6AD1U170
• Device Lot Number: 12244511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male